The 1990's saw a revolution in the technologies underpinning drug discovery. Initiated by genomics, the flood of new potential targets to be addressed demanded dramatic changes in target validation strategies followed by paradigm shifts in lead generation approaches. The ability to rapidly amass gene sequence data also spawned new areas post lead discovery - pharmacogenomics and pharmacogenetics. As development candidates move down the drug discovery/development pipelines, readjustment in preclinical development approaches has also been demanded as new technologies impact on safety assessment and drug metabolism. In turn fundamental changes in approaches to claims in patent applications have occurred without corresponding changes in government patent office policies. As of this writing, while new approaches to lead discovery and optimization are firmly entrenched in the industry there is not yet an impact of this dislocation of traditional approaches on the composition of clinical portfolios. It will be the general theme of the 2001 Keystone meeting to examine the current status of impact of these new technologies and policies.